Endosee

GUDID 00888937013177

Endosee® Hysteroscope with Charging Station/Power Supply/USB Cable

Coopersurgical, Inc.

Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope

• Primary Device ID: 00888937013177
• NIH Device Record Key: f647eaeb-a1d9-47e7-a1a9-70c59a85fa1d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endosee
• Version Model Number: DMES8000
• Company DUNS: 801895244
• Company Name: Coopersurgical, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888937013177 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123151

FDA Product Code

• HIH: Hysteroscope (And Accessories)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-27

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• 00888937013177: Endosee® Hysteroscope with Charging Station/Power Supply/USB Cable
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